Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00465

2 Trial Registration Date

2015-07-23

i Registration Status

Prospective

3 Secondary IDs

2015.005-T

4 Source(s) of Funding

Research Project of Playright by Kuenflower Management Inc. (in honour of Kwong Sik Kwan and Kwong Hui May Kuen) to the UBS Optimus Foundation

5 Primary Sponsor

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

6 Secondary Sponsor

Playright Children's Play Association

Function

Form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chan Wai Man Connie

ii Address

Rm 808, The Nethersole School of Nursing, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T.

iii Phone

3943-9303

iv Email

b138617@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

HKSAR

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Professor Ip Wan Yim

ii Address

Rm 826, The Nethersole School of Nursing, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T.

iii Phone

3943-6229

iv Email

ip2013@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

HKSAR

9 Official Scientific Title of the Study

The stress-reducing effects of therapeutic play on children undergoing cast-removal procedure.

10 Public Title

The stress-reducing effects of therapeutic play on children undergoing cast-removal procedure.

i Public Title in Chinese 研究名稱

治療性遊戲對兒童接受石膏拆除程序的有效性研究

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-03-16

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.005-T

14 Medical Condition Being Studied

Cast-removal in children

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Therapeutic play by hospital play specialists

iii Dosage form of the intervention

behavioural

iv Dosage of the intervention

once only

v Duration of the intervention

about 20 minutes

vi Frequency of the intervention

one time only

16 Comparative Treatments

i Description/ name of comparative treatments

usual care in the orthopaedic out-patient clinic for cast-removal procedure

ii Dosage form of the comparative treatments

usual care

iii Dosage of the comparative treatments

once only

iv Duration of the comparative treatments

about 30 mins

v Frequency of the comparative treatments

one time only

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Children who are 3-12 years of age and their parents are able to speak and understand Cantonese and read Chinese will be invited to join the study.

ii Exclusion Criteria

Children who have had a cast removed within 3 months and have neurological or developmental problems as shown on the medical record will be excluded from the study.

iii Age Minimum

3

iv Age Maximum

12

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

two-arm randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-08-12

21 Target Sample Size

300

22 Recruitment Status

Recruiting

23 Primary Outcome

Anxiety and emotional distress levels of children during the cast-removal procedure

24 Secondary Outcome

Satisfaction levels of parents and cast technicians in respect of the cast-removal procedure (measure at the end of the procedure)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-01-23

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006822

28 Date of Registration in Primary Registry

2015-07-27

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Trial History Detail on 2016-04-05